Outline the stages a new drug moves through from discovery to market approval.
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A drug development pipeline diagram outlines the sequential stages a candidate compound moves through on its way to becoming an approved therapy: discovery and target identification, preclinical research, the three phases of clinical trials, FDA review, and post-market surveillance. It highlights the gates and attrition between phases along with regulatory milestones such as the IND and NDA filings.
Biotech and pharma teams, regulatory affairs professionals, and investors use these diagrams to communicate program status, plan timelines, and explain risk. They appear constantly in investor decks, R&D portfolio reviews, and partnership discussions, where a clear, single-glance view of the development pipeline is essential to the conversation.
It is the sequence of stages a drug candidate passes through, from discovery and preclinical research through clinical trial phases, FDA review, and post-market surveillance.
Phase I tests safety in small healthy groups, Phase II evaluates efficacy and dosing in patients, and Phase III confirms efficacy and monitors side effects in large populations before approval.
Bringing a new drug from discovery to approval typically takes 10 to 15 years, with significant attrition at each phase of the pipeline.
An Investigational New Drug (IND) application is filed before human trials begin, and a New Drug Application (NDA) is submitted to the FDA seeking approval to market the drug.
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